NCT04872426

Brief Summary

The study investigates the relationship between activation of AMP-activated protein kinase (AMPK) in human skeletal muscle and the subsequent improvement in muscle insulin sensitivity for the stimulation of glucose uptake. This will be investigated in young healthy lean male subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
Last Updated

January 21, 2022

Status Verified

April 1, 2021

Enrollment Period

1.3 years

First QC Date

April 29, 2021

Last Update Submit

January 5, 2022

Conditions

Insulin Sensitivity

Keywords

ExerciseGlucose UptakeIschemiaInsulin Sensitivity

Outcome Measures

Primary Outcomes (1)

  • Muscle glucose uptake during exercise and enhanced insulin sensitivity in recovery from exercise.

    Leg glucose uptake is calculated by the arterial-venous difference i blood glucose concentration multiplied with leg blood flow. Sampling of artery and venous blood samples for blood glucose measurements. Measures of artery blood flow by Ultrasound Doppler technique allows a final calculation of glucose uptake across the legs before exercise, during exercise, in recovery from exercise and with insulin stimulation.

    Through study completion, an average of 1 year.

Secondary Outcomes (2)

  • AMPK activity in muscle biopsies

    5 years

  • Posttranslational modification of proteins in muscle biopsies

    5 years

Study Arms (3)

Low intensity exercise

EXPERIMENTAL

70% of maximal leg work load capacity

Other: Exercise, insulin infusion

High intensity exercise

EXPERIMENTAL

70% and 95% of maximal work load capacity (alternately every 5 min)

Other: Exercise, insulin infusion

Low intensity exercise + intermittent ischemia-reperfusion

EXPERIMENTAL

70% of maximal leg work load capacity with intermittent ischemia (25 seconds every 2 min)

Other: Exercise, insulin infusion

Interventions

Exercise, insulin infusionOTHER

Acute one-legged exercise, Insulin infusion 3 hours after one-legged exercise

High intensity exerciseLow intensity exerciseLow intensity exercise + intermittent ischemia-reperfusion

Eligibility Criteria

Age25 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal weight (BMI: below or equal to 27)
  • physical active on a regular basis
  • cardiorespiratory fitness between 40-60 ml/kg/min
  • no history or sign of type 2 diabetes, hypertension, insulin resistance or dyslipidemia

You may not qualify if:

  • smoker
  • BMI: above 27
  • using any kind of medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Insulin ResistanceMotor ActivityIschemia

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 4, 2021

Study Start

August 31, 2018

Primary Completion

January 3, 2020

Study Completion

January 3, 2020

Last Updated

January 21, 2022

Record last verified: 2021-04

Locations

DK(1)